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VITROS HBeAg

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Ortho-Clinical Diagnostics, Inc.
Trade Name
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
5/11/2011
Days to Decision
511 days
Decision Code
APPR
FDA Decision
Approval

VITROS HBeAg

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Ortho-Clinical Diagnostics, Inc.
Trade Name
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
5/11/2011
Days to Decision
511 days
Decision Code
APPR
FDA Decision
Approval